QA Compliance Specialist/Trading Entity Support

Contract Duration: 1 year

Responsibilities:

• Execution of all daily QMS activities such as but not limited to: Write, review and approve SOPs as required Implementation, execution and administration of change controls, deviations and CAPAs.
• Support Trading Entity Compliance group to ensure related GxP activities which support global trading of products are compliant and efficient
• Ensure that a quality management system is implemented and maintained focusing on the management of authorized activities and the accuracy of and quality of records ensuring that relevant customer complaints are dealt with effectively.
• Ensure approval of suppliers and customers
• Support in ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place ensuring that any additional requirements imposed on certain products by national law are adhered to.

Requirements:

• Scientific Degree
• German language is mandatory
• Excellent knowledge of Swiss healthcare legislation, GXP regulations and industry standards
• Strong knowledge of global regulations relating to GDP, licensing, imports/exports and controlled drug / substance compliance.
• GDP, distribution, warehousing and transportation experience or proven equivalent experience
• Ability to collaborate and partner well at all levels, globally, regionally & cross-functionally.
• Highly punctual, systematic, highly organized, & concise in communication
• Strong attention to details, ability to review & managing documentation
• Ability to make decisions on GxP/pharmaceutical activities to ensure regulatory compliance of trading licenses and local regulatory requirements
• Strong partnerships and collaborations to ensure clear definition of requirements and com-pliance to the respective trading licenses.
• A strong understanding of industry and business, applicable legislation and regulatory compliance requirements